Contract development
We are delighted to provide services relating to the development of finished pharmaceutical products, including CTD compilation.
FINISHED DOSAGE FORM DEVELOPMENT
- Formulation and full laboratory-scale development, including lyophilization cycle development and sterilizing filter validation studies
- Photostability and in-use studies
- Production technology development, up-scale and validation of sterile dosage forms – liquid preparations and lyophilized powder preparations in vials
- Production technology transfer to and from third party
- Development, validation and transfer of analytical and microbiological methods according to ICH, Ph. Eur. and Russian Pharmacopoeia requirements
- Development of Finished Dosage Form Registration documentation for EU countries (CTD format)
STABILITY STUDIES FOR FINISHED DOSAGE FORM
- Transfer of analytical and microbiological methods according to ICH, Ph. Eur. and Russian Pharmacopoeia requirements
- Long term, accelerated and intermediate stability studies according to ICH guidelines
INVESTIGATION MEDICINAL PRODUCTS (IMP) DEVELOPMENT
- IMP formulation improvement for phase I – III studies
- IMP production technology development in laboratory conditions and up-scale
- IMP Dossier (CTD) writing for investigational medicinal product